Febraayo 22, 2025, Codsiga Daawada Cusub (NDA) ee duritaanka ipilimumab (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) waxaa aqbashay Xarunta Qiimaynta Daawada (CDE) ee Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) waxaana la siiyay magacaabista Dib-u-eegista Mudnaanta iyadoo lagu darayo sintilimab daaweynta neoadjuvant ee kansarka mindhicirka ee la kala saari karo ee xasillooni-darrada sare leh (MSI-H) ama dayactirka aan isku dheelitirnayn (dMMR).
Kani waa NDA-gii ugu horreeyay ee Shiinaha ee loogu talagalay daawada CTLA-4 ee gudaha ah iyo tallaabo kale oo muhiim ah oo xoojinaysa booska hoggaanka ee sintilimab ee daaweynta difaaca jirka ee kansarka. Daaweynta xannibaadda isbaarada difaaca jirka (ICB) ee bartilmaameedsanaysa PD-1 iyo CTLA-4 ayaa beddeshay daaweynta kansarka, ipilimumab oo leh sintilimab oo ah daaweyn neoadjuvant ah ayaa kordhin karta heerka kala-goynta R0, gaari karta jawaab dhammaystiran oo cudur ah, waxayna yareyn kartaa inta badan bukaanada culayska kiimoterabiga ee adjuvant. Daaweyntan cusub ayaa sidoo kale la filayaa inay yareyso heerka soo noqoshada oo ay horumariso saadaasha muddada-dheer, oo la filayo inay ka faa'iidaysato bukaanada kansarka mindhicirka ee MSI-H/dMMR marka la ansixiyo NDA.
Aqbalaadda iyo Dib-u-eegista Mudnaanta ee NDA waxay ku salaysan yihiin natiijooyinka ka soo baxay tijaabo caafimaad oo aan kala sooc lahayn, la xakameeyey, oo xarun badan leh, oo muhiim ah (NeoShot, NCT05890742) oo qiimaysay badbaadada iyo waxtarka ipilimumab oo lagu daray sintilimab oo ah daaweynta neoadjuvant iyo marka la barbar dhigo qalliinka tooska ah ee xagjirka ah ee kansarka mindhicirka MSI-H/dMMR. Dhibcaha ugu horreeya waa heerka jawaab celinta dhammaystiran ee cudurka (pCR) iyo badbaadada aan dhacdooyinka lahayn (EFS). Falanqaynta ku-meel-gaarka ah ee Guddiga Kormeerka Xogta Madaxa-bannaan (IDMC) waxay muujisay in tijaabada NeoShot ay gaartay heerkeedii ugu horreeyay.
Laga bilaabo Febraayo 4, 2024, 101 dhibcood ayaa la diiwaangeliyey (ragga: 55.4%, da'da dhexdhexaadka ah: 56 sano, ECOG PS 1: 54.5%, khatar sare: 76.2%) waxaana loo kala soocay gacanta A (n = 52) iyo gacanta B (n = 49). Gacanta A, 1 dhibcood ayaa hore u joogsaday daaweynta (ka bixitaan). Gacanta B, 4 dhibcood ayaa hore u joogsaday daaweynta (1 ka bixitaan, 1 dhintay, 2 ayaa sii waday neoadjuvant sintilimab). Qalliinka daaweynta ee la qorsheeyay ayaa lagu sameeyay 51 dhibcood (98.1%) gacanta A iyo 45 (91.8%) gacanta B. Qiimaynta qalliinka kadib waxay muujisay in si aan isku mid ahayn loo hagaajin karo (pMMR) 1 dhibcood midkiiba gacanta A iyo gacanta B. Heerarka pCR waxay ahaayeen 80.0% (40/50, 95%CI: 66.3-90.0) gacanta A marka loo eego 47.7% (21/44, 95%CI: 32.5-63.3) gacanta B (p = 0.0007). Dhammaan bukaannada qalliinka lagu sameeyay waxaa laga saaray R0. Waqtiga dhexdhexaadka ah ee u dhexeeya qiyaasta koowaad ee daaweynta neoadjuvant iyo qalliinka wuxuu ahaa 47 maalmood (inta u dhaxaysa: 35-82). Dib u dhac ku yimid qalliinka ayaa ku dhacay 3 dhibcood oo ay ku jiraan 2 dhibcood oo gacanta A ah oo ay ugu wacan tahay hypothyroidism-ka heerka 2aad (dib u dhac 2 maalmood ah) iyo hyperthyroidism-ka heerka 1aad (dib u dhac 13 maalmood ah), iyo 1 dhibcood oo gacanta B ah sabab kale awgeed (dib u dhac 26 maalmood ah). Dhacdooyinka soo noqnoqda ee daaweynta (TEAEs) waxay ka dhaceen 46 dhibcood (88.5%, heerka 3aad 13 dhibcood) gacanta A iyo 39 dhibcood (79.6%, heerka 3aad 9 dhibcood) gacanta B. Dhacdooyinka soo noqnoqda ee la xiriira difaaca jirka (IRAEs) waxay ka dhaceen 22 dhibcood (42.3%) gacanta A iyo 18 dhibcood (36.7%) gacanta B. Heerka 3aad irAEs waxay ka dhaceen 3 dhibcood oo gacanta A ah, oo ay ku jiraan myocarditis-ka difaaca jirka, ileus iyo enteritis-ka, iyo 4 dhibcood oo gacanta B ah, oo ay ku jiraan alanine aminotransferase oo kordhay, finan, hypothyroidism iyo myocarditis. TRAE-yada halista ah waxay ka dhaceen 4 (7.7%) dhibcood gacanta A iyo 3 (6.1%) dhibcood gacanta B. TRAE taasoo keentay dhimasho waxay ka dhacday 1 dhibcood gacanta B (myocarditis).
Ku saabsan Ipilimumab
Ipilimumab (Koodhka R&D: IBI310) waa duritaan dhammaystiran oo ah unugyo difaaca jirka oo si madax-bannaan u sameeya Innovent. Ipilimumab wuxuu si gaar ah u xiri karaa antigen 4 oo la xiriira cytotoxic T lymphocyte (CTLA-4), taasoo xannibaysa xannibaadda unugyada T ee dhexdhexaadka ah ee CTLA-4, kor u qaadida dhaqdhaqaaqa iyo koritaanka unugyada T, hagaajinta jawaabta difaaca jirka ee burooyinka, iyo gaaritaanka saameynta ka hortagga burooyinka.
NDA ee ipilimumab oo lagu daray sintilimab oo ah daawaynta neoadjuvant ee kansarka mindhicirka ee microsatellite-ka ah ee la kala saari karo (MSI-H) ama kansarka mindhicirka ee aan isku dheelitirnayn (dMMR) ayaa hoos yimaada dib u eegista NMPA waxaana la siiyay magacaabista Dib u eegista Mudnaanta.
Ku saabsan Sintilimab
Sintilimab, oo loo suuq geeyo TYVYT (durista sintilimab) ee Shiinaha, waa antibody monoclonal PD-1 immunoglobulin G4 oo ay si wadajir ah u sameeyeen Innovent iyo Eli Lilly iyo Company. Sintilimab waa nooc ka mid ah antibody-ga immunoglobulin G4 monoclonal, kaas oo ku xidha molecules-ka PD-1 ee dusha sare ee unugyada T, wuxuu xannibaa marinnada PD-1 / PD-Ligand 1 (PD-L1), wuxuuna dib u hawlgeliyaa unugyada T si ay u dilaan unugyada kansarka.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
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Tixraacyada
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
Waqtiga boostada: Febraayo-25-2025